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Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

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ClinicalTrials.gov Identifier: NCT00584948
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : April 10, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Forest Laboratories
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE December 22, 2007
First Posted Date  ICMJE January 2, 2008
Results First Submitted Date  ICMJE June 27, 2014
Results First Posted Date  ICMJE April 10, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE September 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II) [ Time Frame: One Year ]
    The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance.
  • Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale [ Time Frame: 1 year ]
    The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
Improvement in neurocognitive functioning [ Time Frame: One Year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
Improvement in Cognitive ERP Deficits [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome
Official Title  ICMJE Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine
Brief Summary The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fragile X-Associated Tremor/Ataxia Syndrome
  • Fragile X Premutation Carriers
Intervention  ICMJE
  • Drug: Memantine
    Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
    Other Name: Namenda
  • Drug: Placebo
    Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
Study Arms  ICMJE
  • Experimental: Memantine
    Intervention: Drug: Memantine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Seritan AL, Nguyen DV, Mu Y, Tassone F, Bourgeois JA, Schneider A, Cogswell JB, Cook KR, Leehey MA, Grigsby J, Olichney JM, Adams PE, Legg W, Zhang L, Hagerman PJ, Hagerman RJ. Memantine for fragile X-associated tremor/ataxia syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Mar;75(3):264-71. doi: 10.4088/JCP.13m08546.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2017)
94
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2007)
180
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5

Exclusion Criteria:

  • Previous reaction to memantine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00584948
Other Study ID Numbers  ICMJE 200715426-1
1RL1AG032115-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • Forest Laboratories
Investigators  ICMJE
Principal Investigator: Randi J Hagerman, MD University of California, Davis
PRS Account University of California, Davis
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP